Class IIOngoingZ-2677-2026
ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in.
Surgical dressing manufactured out of specification (greater thickness).
ConvaTec, IncNCJul 15, 2026
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–6 of 6 recalls
Surgical dressing manufactured out of specification (greater thickness).
Drainable large pouch may leak due to manufacturing issue.
Drainable large pouch may leak due to manufacturing issue.
Drainable large pouch may leak due to manufacturing issue.
Wound dressing may have foreign matter on the product.
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling.…